Commercial Insight: Antihormonal Cancer Therapies - Leading brands strive to minimize generic sales erosion

Introduction

Antihormonal cancer therapies are a class of drugs used predominantly in the treatment of breast cancer and prostate cancer. The high incidence of these tumor types translates into a significant commercial potential for drug developers. Collectively, the antihormonal therapy cancer brands generated sales of about $7.0 billion in the seven major pharmaceutical markets in 2009.

Scope

*In-depth analysis of the current and future antihormonal therapies market across the US, 5EU and Japan, plus a rest of world snapshot

*Antihormonal therapy sales forecasts for brands and generics from 2009 to 2019

*Assessment of the leading cancer brands and drug classes to identify key success factors within this sector

*Evaluation of the strategies of leading players in the antihormonals market

Highlights

The antihormonals market was worth $7.0 billion in 2009 across the seven major pharmaceutical markets. Datamonitor forecasts the antihormonals market will shrink marginally in the forecast period 20092019, at a CAGR of negative 0.7%.

In 2019 the top three brands in terms of forecast sales will be Arimidex, Lupron (leuprolide; Takeda/Abbott) and Casodex (bicalutamide; AstraZeneca). Despite losing around 54% of its current sales value to generic competitors, Arimidex will retain its market leading position.

In a mature market, the importance of product lifecycle management is high. AstraZeneca was the key player in the market in 2009, with an antihormonals portfolio valued at over $3.2 billion. With successful lifecycle management and a considerable investment in marketing activities, AstraZeneca has built a strong brand presence for its products.

Reasons to Purchase

*Quantify the performance of each of the marketed antihormonal therapy cancer brands in the seven major markets over the period 2009 to 2019

*Acquire a detailed account of antihormonal therapy cancer brand dynamics and the events that drive and limit their market growth

*Benchmark antihormonal therapy cancer brands against their generics and rest of class and align their 7MM performance with a rest of world snapshot

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OVERVIEW 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Oncology pharmaceutical analysis team 2
EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the antihormonal cancer therapies market 3
Related reports 4
Upcoming related reports 4
Table of Contents 5
MARKET DEFINITION 6
Definition of the cancer market 6
Antihormonal therapies by ATC class 6
L2A3 - Luteinizing hormone-releasing hormone agonists 6
L2B1 - Anti-estrogens 7
L2B2 - Anti-androgens 7
L2B3 - Aromatase inhibitors 7
L2B9 - Other hormone antagonists 7
MARKET OVERVIEW 9
Seven major markets 10
Current and future market overview 10
The antihormonals market will shrink marginally in the forecast period 10
Patent expiries of leading antihormonal brands are set to occur within the next 5 years 10
The US will suffer the greatest impact of generic erosion, losing around 25% of its value over the forecast period 12
The aromatase inhibitors will continue to be the leading drug class in 2019 13
The current leading antihormonal brands will suffer generic sales erosion but will maintain a high level of sales 14
The antihormonal therapies market will shrink from $7.0 billion in 2009 to $6.5 billion in 2019 across the seven major pharmaceutical markets 15
Opportunities and threats 17
Opportunity 1: aging population will result in increasing cancer incidence 17
Opportunity 2: oncology therapy sales continue to experience strong growth 18
Opportunity 3: high levels of unmet need 19
Threat 1: Pharma's transition towards specialist secondary care indications may further competition in the oncology market 20
Threat 2: the cost of drug development continues to rise 20
Threat 3: ongoing cost-containment measures 20
US 21
Current and future market assessment 21
The US antihormonals market will suffer the greatest impact of generic sales erosion 21
Opportunities and threats 25
Opportunity 1: the US's large population and high healthcare expenditure will continue to offer commercial opportunities for drug developers 25
Opportunity 2: healthcare reform will boost the number of insured in the US 25
Opportunity 3: closure of the Medicare Part D coverage gap is good news for branded Pharma 26
Threat 1: growing regulatory pressures increase costs and decrease market penetration for Pharma 26
Threat 2: patent expiries and the resulting generic competition will erode branded sales revenues 27
Threat 3: the US health reform law will intensify cost-containment pressures 27
Japan 28
Current and future market assessment 28
The antihormonals market in Japan is forecast to grow over the forecast period 28
Opportunities and threats 32
Opportunity 1: the aging population represents a large and growing patient base 32
Opportunity 2: generic sales erosion remains low in Japan 32
Opportunity 3: decrease in lag times for launch of new drugs could accelerate new launches 33
Threat 1: government-enforced biennial cuts continue to have a negative effect on market growth 33
Threat 2: healthcare proposal to change current pricing system will be of limited benefit to Japanese Pharma 34
Threat 3: encouraging decrease in lag times for launch of new drugs 34
Five major European markets (5EU) 36
Current and future market assessment 36
The antihormonals therapies market in the five European countries will show marginal growth 36
The antihormonal therapies market will grow from $2.6 billion in 2009 to $2.7 billion in 2019 in the five major European markets 38
Opportunities and threats 40
Opportunity 1: EU Cancer Task Force will improve the availability of information while generating funds for research 41
Opportunity 2: reorganization of the European Medicines Agency (EMA) expected to streamline EU regulatory process 41
Threat 1: new European drug price reductions are likely to affect pharma industry growth 41
Threat 2: higher generic uptake in less mature EU markets will impact branded sales revenues 42
Threat 3: EC inquiry into delays in generics market entry will have wide-ranging ramifications for the branded and generics industry 43
Threat 4: Spain's price cuts and reference groups are driving drug prices down 44
Threat 5: new low reimbursement rate created in France signals the growing pressure for cost-containment 44
Threat 6: NICE will remain a significant hurdle to commercialization of cancer drugs in the UK, despite relaxation of its cost-effectiveness criteria 45
Threat 7: Germany's new cost-effectiveness analysis system could add to the downward pressure on drug prices 46
Threat 8: additional cuts to the price of oncology drugs in Italy are impending under its pay-for-performance scheme 47
France 48
Current and future market assessment 48
The antihormonal therapies market in France will peak at around $654m in 2010. 48
Germany 51
Current and future market assessment 51
The antihormonals therapies market will grow from $727m in 2009 to $835m in 2019 in Germany 51
Italy 55
Current and future market assessment 55
The antihormonal therapies market will grow from $484m in 2009 to $512m in 2019 in Italy 55
Spain 58
Current and future market assessment 58
The antihormonals market in Spain will marginally shrink from $418m in 2009 to $396m in 2019 in Spain 58
UK 61
Current and future market assessment 61
The antihormonal therapies market will grow from $333m in 2009 to $348m in 2019 in the UK 61
Rest of the world snapshot 65
Current market assessment 65
Rest of the world sales represent 18% of the global antihormonals market 65
Opportunities and threats 66
Opportunity 1: incidence of cancer is forecast to increase in the BRIC countries 66
Opportunity 2: emerging markets continue to attract pharma companies despite challenges 67
Threat 1: cost of new therapies is a barrier to market penetration 67
BRAND DYNAMICS 68
Overview of competitive landscape 68
Arimidex, Lupron and Casodex will be the top three antihormonal brands in 10 years time 68
Drivers of brand choice 69
Efficacy and toxicity are the most important drivers of brand choice 69
Trends in marketing strategies 70
Marketing strategy for leading brands 70
Patient information and support programs 71
Direct-to-consumer advertising 73
Arimidex (anastrozole; AstraZeneca) 74
Drug profile 75
Product positioning 75
SWOT analysis 76
Brand forecast to 2019 77
Arimidex set to lose 54% of its current sales value to generic competitors 77
Lupron (leuprolide; Takeda/Abbott) 81
Drug profile 81
Product positioning 81
SWOT analysis 83
Brand forecast to 2019 83
Lupron will be the top selling antihormonal therapy in 2019, with sales in excess of $1 billion 83
Casodex (bicalutamide; AstraZeneca) 85
Drug profile 86
Product positioning 86
SWOT analysis 87
Brand forecast to 2019 88
Patent expiries set to hamper sales of this class-leading brand 88
KEY DEVELOPERS 90
Strategic overview 90
Trends in corporate strategy 91
Strategic lifecycle management is essential in the antihormonals market 91
Commercialization partnerships are common for smaller players 91
AstraZeneca 91
Corporate strategy 91
Oncology antihormonals portfolio assessment 92
Takeda 93
Corporate strategy 93
Oncology antihormonals portfolio assessment 93
Portfolio assessment of other leading companies 94
BIBLIOGRAPHY 96
Journal papers 96
Websites 96
Datamonitor reports 101
Other 102
APPENDIX A - MARKET ASSUMPTIONS 103
Forecasting assumptions 103
New product launches 103
Patent expiries 103
Data definitions, limitations and assumptions 104
Standard units 104
Country group definitions 104
Rest of the World 104
The 'all other EU countries' group 104
The 'Other non-EU countries' group 104
Forecast methodology 105
Derivation of sales forecasts and pricing trends 105
Exchange rates 105
Report methodology 106
APPENDIX B 107
About Datamonitor 107
About Datamonitor Healthcare 107
About the Oncology analysis team 108
Disclaimer 110
List of Tables
Table 1: Definition of the cancer market, 2010 6
Table 2: Sales and growth of antihormonal therapy drug classes in the seven major pharmaceutical markets ($m), 2009-2019 10
Table 3: Key events impacting the antihormonal therapies market in the seven major markets, 2009-2019 11
Table 4: Antihormonal therapy sales forecasts in the seven major markets ($m), 2009-2019 16
Table 5: Summary of opportunities and threats that will impact the antihormonals market across the seven major markets, 2009-2019 17
Table 6: Sales and growth of antihormonal therapy drug classes in the US ($m), 2009-2019 21
Table 7: Top 5 branded antihormonals in the US in 2009 and 2019 23
Table 8: Antihormonal therapy sales forecasts in the US ($m), 2009-2019 24
Table 9: Summary of opportunities and threats to impact the antihormonals market in the US, 2009-2019 25
Table 10: Sales and growth of antihormonal therapy drug classes in Japan ($m), 2009-2019 28
Table 11: Top 5 branded antihormonals in Japan in 2009 and 2019 30
Table 12: Antihormonal therapy sales forecasts in Japan ($m), 2009-2019 31
Table 13: Summary of opportunities and threats to impact the antihormonals market in Japan, 2009-2019 32
Table 14: Sales and growth of antihormonal therapy drug classes in the five major EU markets ($m), 2009-2019 36
Table 15: Top 5 branded antihormonals in the five major EU markets in 2009 and 2019 38
Table 16: Antihormonal therapy sales forecasts in the five major EU markets ($m), 2009-2019 39
Table 17: Summary of opportunities and threats to impact the antihormonals market in the five major EU markets, 2009-2019 40
Table 18: Risk-sharing agreements between NICE and selected pharma companies in the UK, 2009-2010 46
Table 19: Sales and growth of antihormonal therapy drug classes in France ($m), 2009-2019 48
Table 20: Top 5 branded antihormonals in France in 2009 and 2019 49
Table 21: Antihormonal therapy sales forecasts in France ($m), 2009-2019 50
Table 22: Sales and growth of antihormonal therapy drug classes in Germany ($m), 2009-2019 51
Table 23: Top 5 branded antihormonals in Germany in 2009 and 2019 53
Table 24: Antihormonal therapy sales forecasts in Germany ($m), 2009-2019 54
Table 25: Sales and growth of antihormonal therapy drug classes in Italy ($m), 2009-2019 55
Table 26: Top 5 branded antihormonals in Italy in 2009 and 2019 56
Table 27: Antihormonal therapy sales forecasts in Italy ($m), 2009-2019 57
Table 28: Sales and growth of antihormonal therapy drug classes in Spain ($m), 2009-2019 58
Table 29: Top 5 branded antihormonals in Spain in 2009 and 2019 59
Table 30: Antihormonal therapy sales forecasts in Spain ($m), 2009-2019 60
Table 31: Sales and growth of antihormonal therapy drug classes in the UK ($m), 2009-2019 61
Table 32: Top 5 branded antihormonals in the UK in 2009 and 2019 63
Table 33: Antihormonal therapy sales forecasts in the UK ($m), 2009-2019 64
Table 34: Comparison of antihormonal drug class sales in the US, Japan, five major EU markets and Rest of the world markets ($m), 2009 66
Table 35: Leading branded antihormonal therapy drug sales in the seven major markets ($m), 2009-2019 68
Table 36: Marketing strategies employed by companies behind the top three antihormonal brands, 2010 71
Table 37: Arimidex (anastrozole) - drug profile, 2010 75
Table 38: Factors impacting revenues of Arimidex, 2009-2019 79
Table 39: Lupron (leuprolide) - drug profile, 2010 81
Table 40: Factors impacting the revenues of Lupron, 2009-2019 85
Table 41: Casodex (bicalutamide) - drug profile, 2010 86
Table 42: Factors impacting the revenues of Casodex, 2009-2019 89
Table 43: Leading companies in the antihormonals market in the seven major pharmaceutical markets ($m), 2009-2019 90
Table 44: Assessment of AstraZeneca's cancer antihormonals portfolio, 2010 92
Table 45: Assessment of Takeda's cancer antihormonals portfolio, 2010 93
Table 46: Assessment of Novartis's cancer antihormonals portfolio, 2010 94
Table 47: Assessment of Pfizer's cancer antihormonals portfolio, 2010 94
Table 48: Assessment of Sanofi-Aventis's cancer antihormonals portfolio, 2010 95
Table 49: Regional launch dates for new antihormonals in the seven major markets, 2010-2019 103
Table 50: Patent expiry dates for the approved antihormonals in the seven major pharmaceutical markets, 2010-2019 103
List of Figures
Figure 26: Methodology for forecasting price to remove impact of currency fluctuations on future trend 105

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